Psilocybin Therapy in New Jersey: Where FDA Approval and the State Law Stand (November 2026)

Labyrinth Psychiatry Group · Published November 6, 2026 · Prepared by the practice’s editorial team · Reviewed by Dr. Salvatore G. Savatta on November 6, 2026

The short answer

Not yet. As of November 6, 2026, no psilocybin treatment has FDA approval, and outside a research study psilocybin therapy is not something a New Jersey clinic can offer you. The first approval may be getting close. On November 3, Compass Pathways said the final part of its FDA application for COMP360, a synthetic psilocybin treatment for treatment-resistant depression, “will be filed in the next two weeks,” and that it expects a U.S. launch in the first half of 2027, “subject to FDA approval.”

Approval would not be the last step. Compass says COMP360 contains a Schedule I controlled substance and “must be rescheduled before commercializing,” by the DEA and by the states. And New Jersey’s own psilocybin law, signed January 20, 2026, pays for research at three hospitals. It does not license clinics, service centers or facilitators.

Where FDA approval stands: the timeline

Each row comes from the source named in it. The most important line is the last one: no FDA decision date has been announced.

What still has to happen after an FDA decision

• The FDA review. The FDA issued national priority vouchers on April 24, 2026 for psilocybin in treatment-resistant depression and psilocybin in major depressive disorder. Compass says its voucher “could shorten review times to 1-2 months.” That is a target, not a promised date.
• Rescheduling. An April 18, 2026 executive order tells the Attorney General to “initiate and complete review of any product containing a Schedule I substance that has successfully completed Phase 3 clinical trials for a serious mental health disorder,” so rescheduling “may proceed as quickly as practicable” for products the FDA approves. The order itself approves nothing.
• How it would be given. In research, the FDA’s July 2026 guidance expects “observation by two monitors for the duration of the treatment session,” because people “may remain in a vulnerable state for several hours or longer,” and, when the lead monitor is not a physician, an on-call physician able to reach the site within 15 minutes. The rules for an approved product would come with its approval.
• Who it would be for. COMP360 has been studied in treatment-resistant depression. A second psilocybin program, for major depressive disorder, also holds an FDA priority voucher.

New Jersey’s 2026 psilocybin law, in plain terms

Governor Murphy signed P.L.2025, c.296 on January 20, 2026. Earlier versions of the bill would have set up “a framework for the regulated production and use of psilocybin.” Assembly amendments adopted January 12, 2026 replaced that with a research pilot, and the pilot is what became law.

• What it creates: the “Psilocybin Behavioral Health Access and Therapy Pilot Program” in the New Jersey Department of Health, with an 11-member Psychedelic Therapy and Research Advisory Board.
• Where: one hospital from each of the northern, central and southern regions. Union County, where Cranford is, is in the central region with Middlesex, Monmouth and Mercer counties.
• Money: $6 million, with $2 million to each of the three hospitals.
• Rules: the Department of Health may not set any requirement that “conflicts with protocols and guidelines from the United States Food and Drug Administration related to clinical trials for psychedelic substances.”
• Timing in the law: board members within 60 days; a request for proposals to hospitals within 180 days (about mid-July 2026); hospitals chosen within 60 days after that. The pilot “shall commence upon the selection of hospitals,” and reports follow year two.
• What it does not do: license service centers, facilitators or sales. The enacted text also sets no age or certificate rule for patients; who can take part will depend on each hospital’s research protocol.

As of November 6, 2026, we found no public announcement that the Department of Health has chosen the three hospitals. Until it does, there is no pilot to join.

Other states. Two states license psilocybin programs. In Oregon, adults 21 and older can receive psilocybin services at a licensed service center with a licensed facilitator, with no prescription; Oregon notes psilocybin is “still a Schedule I substance” under federal law. Colorado listed 12 standard and 35 micro licensed healing centers as of October 30, 2026.

What the research shows so far

The results below are what each study or company reported, shown as the share of people who responded and the share in remission. A response means a person’s depression score fell by at least half. Remission means the score fell low enough that few or no symptoms were left. Compass has not announced those two figures for its Phase 3 trials, so those rows show what the company has reported.

In short: in the two published trials that compared one 25 mg dose with a placebo-like dose, about 4 in 10 people responded (37% and 42%), against 1 to 2 in 10 in the comparison groups (18% and 11%), and about 3 in 10 were in remission (29% and 25%), against about 1 in 10 (8% and 9%). The 2022 trial’s authors caution that “no definite conclusions can be drawn” from its response and remission figures, because of how the trial’s statistics were planned. The 2021 head-to-head trial found no significant difference from escitalopram on its main measure. Both Phase 3 trials met their main goal, according to Compass, but the company has not announced their response and remission rates. Compass reports that in its Phase 3 trials, side effects were mostly mild or moderate and “the vast majority resolving within 24 hours.” Dr. Savatta wrote about the 2021 study for this site at the time; his piece, What effect will psilocybin have on the treatment of depression?, now carries a note pointing here.

Safety, and who may not be a candidate

• Common side effects. In COMP005, the most common were “headache, nausea and visual hallucination.” In the 2022 NEJM trial, adverse events occurred in 179 of 233 participants (77%) and included headache, nausea and dizziness.
• Heart and blood pressure. NIDA: “Psilocybin typically raises blood pressure and heart rate, which may be dangerous for people with heart conditions.”
• Suicidal thoughts. In the 2022 NEJM trial, “suicidal ideation or behavior or self-injury occurred in all dose groups,” including the 1 mg group.
• Who the trials left out. Compass’s first Phase 3 trial (COMP005) excluded anyone with past or current bipolar disorder or any psychotic disorder, a psychiatric hospital stay in the past 12 months, or TMS in the six months before screening. Another Phase 3 trial (NCT06308653) excluded people with elevated blood pressure, certain heart conditions, or a first-degree relative with a psychotic disorder or bipolar I disorder. These are research rules; an approved label could differ.
• Supervision. In research, the FDA expects two monitors for the whole session, as described above.

Why not to try it on your own

NIDA says the health risks of psilocybin show up “particularly when unsupervised and outside of a research study and clinical supervision,” and that “some commercial products such as candies marketed as containing psilocybin have also been found to contain toxic chemicals and have caused severe illness.” In 2024, the CDC counted 180 illnesses, 73 hospitalizations and 2 deaths linked to Diamond Shruumz brand chocolate bars, cones and gummies and similar mushroom-marketed chocolates, 3 of them in New Jersey. FDA testing of the products found psilocin, pregabalin (a prescription drug) and other substances, and CDC warns such edibles “might contain undisclosed ingredients.” If someone has taken a product like this and is very unwell, call 911.

If you are thinking about psilocybin for your depression now

1. Talk with a psychiatrist about where you are. How many treatments you have tried, for how long and at what dose shapes what makes sense next, including whether you would be a candidate for psilocybin later.
2. Look at clinical trials, with care. On November 6, 2026, ClinicalTrials.gov listed 11 recruiting studies within about 60 miles of Cranford that match a psilocybin search, most in New York City. The only New Jersey site was in Toms River, for CYB003, a compound related to psilocybin, in major depressive disorder. Each trial sets its own rules; Compass’s first Phase 3 trial excluded anyone who had TMS in the six months before screening.
3. Know what is available today. For depression that has not responded to antidepressants, Labyrinth offers TMS therapy and SPRAVATO (esketamine) in Cranford. SPRAVATO is given only in certified healthcare settings, with at least two hours of observation. TMS vs. SPRAVATO compares the two.
4. Stay in care while you wait. No approval date exists yet. If you are waiting, keep your current treatment and your psychiatrist in the loop rather than stopping anything on your own.

Psilocybin at Labyrinth Psychiatry Group

Labyrinth sees psilocybin as a promising treatment and hopes to offer it as soon as it is available and appropriate safeguards are in place. The practice does not offer it today, and this page will be updated as the FDA, the DEA and New Jersey act.

If your depression has not responded to treatment, the practice can evaluate you for the options available now at 11 Commerce Drive, Lobby Floor, Cranford, NJ 07016. Call 908-336-1187 or use the appointment request form; office staff follow up to arrange a time. For more, see treatment-resistant depression.

Questions people ask about psilocybin in New Jersey